Economic evaluations of Pharmaceuticals are increasingly being conducted in conjunction with randomized phase III clinical trials to meet the demand for pharmacoeconomic data when new products are launched. While the need for such data is often global, the trials in which relevant information may be collected are often conducted in only one or a limited number of countries. A critical issue is how data from pivotal clinical trials in one setting can serve as the basis for pharmacoeconomic evaluations in others. We address this issue and report on four economic evaluations that we undertook in conjunction with a recent U.S. phase III clinical trial of recombinant human deoxyribonuclease (rhDNase), which is used to improve pulmonary function in patients with cystic fibrosis (CF). The objective of these evaluations was to estimate the potential impact of rhDNase therapy in France, Germany, Italy, and the United Kingdom on the direct costs of medical care for the treatment of respiratory tract infections (RTIs) in patients with CF. Analyses of economic impact were undertaken

This paper presents a discussion of the historical development of deinstitutionalization in the United States, including the political, ideological, and social origins of that policy. The outcomes of deinstitutionalization are considered, including the impact of the policy on the quality of life of people with severe mental disorders. The authors also provide a brief review of the literature on the efficacy and cost-effectiveness of hospitalization versus outpatient (community) care. Recent developments in the use of involuntary hospitalization are discussed, along with a number of important trends in the delivery and financing of services for persons with severe mental disorders.

The ethical principles of beneficence (doing the best for one's patients and clients), nonmaleficence (doing no harm), autonomy, justice, and equity, are positively associated with the quality of a trial rather than being opposed to it. Ethical considerations involve such important questions as appropriate design and documentation, participation rates, withdrawals or losses to follow-up, careful monitoring of safety and efficacy, timely completion, generalizability, and publication and dissemination of findings. When conflicts between ethical considerations and the trial's scientific quality do occur, the ethical considerations must be paramount.

The U.S. National Institutes of Health (NIH) Consensus Development Program (CDP) Guidelines have undergone some modifications over the program's 18-year history. They have never been published in archival form. This article reviews the evolution of the NIH CDP Guidelines and then presents the complete 1995 version.

There is much variation in the provision of clinical pharmacy services in U.K. National Health Service hospitals. Some services are provided in groups and there are differences in the extent to which barriers exist to the provision of services. Factors that linked services included efficient use of resources; barriers involved a requirement for pharmacists to participate in multidisciplinary teams. The strong resemblances between service uptake by hospital pharmacies and the technology diffusion model provides insight into the future development of services in this era of evidence-based care.

New models for determining the cost of care and length of stay in the neonatal intensive care unit (NICU) were developed using financial and clinical data from 588 admissions to our NICU. The model for determining costs explained 71% of the variability in total hospital costs. Models such as the ones developed in this study can be used to compare costs in different institutions, determine temporal trends in costs, and examine the financial impact of using new technologies. Such models can also be useful components of a rational prospective pricing system for the NICU.

The Basaglia movement in Italian psychiatry is described and analyzed in several contexts: the historical, the cultural, and the “practical” in terms of outcomes. Those who began the movement of democratic psychiatry grasped interesting elements of “critical theory”: the definitions of madness, power structures, and medical discourse itself. A backward look at the sea change, however, reveals states and rates of dysfunction that disappoint and indicate that political ideology divorced from cultural awareness can often harden the opposition.

The most reliable information on any type of medical intervention is provided by the results of randomized clinical trials (RCTs). In response to increasing pressure to make effective use of limited resources, increasing numbers of health professionals rely on the medical literature, in particular reports of RCTs. However, RCTs may be influenced by a number of factors that introduce bias during the conduct, analysis, and reporting of the trial. Trials may be described as random, when in fact only quasi-random means of treatment allocation have been used; patients may be selectively removed from the analysis; and the report may restrict presentation to or give undue emphasis to only the analyses that yield positive results. The implications of such bias are discussed with particular reference to the effect that they may have on reviews and meta-analyses.

Consumerism is a growing phenomenon in U.S. health care, yet its exercise is still inhibited by powerful forces within the medical community. Despite the neuroscientific framework that stresses the commonalities between mental and physical illness, consumerism is even more problematic and difficult in mental health care than in other areas of health care. People with severe mental illness and their advocates must contend with limited public understanding of neurobiological disorders, poor definitions of effective treatment, and a paucity of outcome data, especially from prospective randomized and long-term studies. The only clear way for consumerism to grow in mental health care is for its advocates to align themselves with the neuroscientific revolution and to demand that effective and equitable treatment programs be created based on the documented evidence of the physical nature of neurobiological disorders.

A complete and comprehensive search of the relevant evidence is an essential step in the preparation of a scientific systematic review. The Cochrane Pregnancy and Childbirth Database consists of some 600 systematic reviews, based on almost 6,000 randomized or quasi-randomized trials of care during pregnancy and childbirth. As ascertainment from electronic search of the National Library of Medicine MEDLINE database was not complete, the mainstay of our search strategy was a systematic hand search of some 60 journals, beginning with volumes published in 1950. Additional references were obtained from the list of references in primary research reports and conference reports. A major effort was made to identify unpublished trials and to obtain unpublished data from published trials.

The anticipated demographic changes with an increasing number of elderly force us to plan and use health care resources more efficiently. In this study we have used the components of a case-mix measure for nursing homes; the Resource Utilization Groups (RUG-II), to predict length of stay (LOS) and outcome in geriatric institutions. We have shown that the RUG categories and an activities of daily living (ADL) index differ significantly in both respects, but that other variables might be of more clinical value when establishing a prospective payment system, based on LOS in geriatric institutions.

This study examines, on a per-case basis, the social costs associated with contraceptive failures and resulting term pregnancies. To combat unintended pregnancy and escalating health care costs, the public sector needs to provide greater access to highly effective methods of contraception.

The use of research evidence depends on more than its quality. If one considers other factors that influence the use of evidence, the quantity of accessible evidence and initiatives ensuring a wider understanding of it must be equally important. In consequence, improving the quality of research evidence alone will not necessarily lead to its greater use.

Changing compliance with medication directives can greatly affect health outcomes. To assess programs that influence compliance, accurate measurement of compliance is essential. All currently available methods are imperfect. This paper suggests a new method—the “randomized response interview”—along with a strategy for its implementation.

A cost-effectiveness analysis is part of the U.K. ECMO Trial. In preparation for this analysis, existing evidence on the costs and effectiveness of neonatal ECMO was evaluated. ECMO appears to be more costly but may be more or less effective than conventional treatment. No case can be made for introducing ECMO before trial results are available.

The use of electroconvulsive therapy (ECT), controversial since its inception, offers an instructive case study on the challenge of addressing patients' perspectives in the evaluation of health care technology. Despite widespread professional acceptance of ECT, groups of former psychiatric patients have worked through the U.S. legal system to restrict and even ban ECT in the treatment of mental illness. This unusual lay participation in the regulation of health care illustrates how differing conceptions of evidence can affect the evaluation of technology. ECT provides a powerful example of the value of a more complex definition of the significant outcomes of treatment and the growing practice of outcomes assessment, especially as such research is used to shape health policy.

Health technology assessment has predominantly been carried out by scientific and health policy experts, but the involvement of users is becoming increasingly important. At present, robust examples of the integration of lay knowledge in health technology assessment are limited, but examination of examples in other fields of health policy decision making can provide important pointers for the development of valid methodologies.

We examined staffing levels, acquisition of medical technologies, and utilization of those technologies in private and government teaching hospitals in Japan. Adjusting for size and case mix, we found that government hospitals acquire more technology, use that technology less, and employ a more highly skilled staff than do private hospitals.

Mental health services depend both on efficacious drug and interpersonal interventions and strategies for financing, organizing, and delivering these services. In recent years, much attention has been devoted to approaches that seek to coordinate needed care and to provide it in the most cost-effective ways. Cost constraints encourage the substitution of alternative community treatments for expensive inpatient care and the identification of appropriate ways to link effectively the varying care components. The mechanism most commonly advocated is case management, but the concept is applied in diverse ways and has little agreed upon meaning and disparate outcomes. This paper discusses and evaluates concepts of case management and a variety of other systems interventions designed to reduce fragmentation. It also reviews approaches to managed care, including mental health capitation and utilization management. New organizational technologies are likely to change dramatically professional practices and standards and the future provision of mental health care.

Methods often used for the valuation of health states are the time trade-off (TTO) and the visual analog scale (VAS). The VAS is easier than the TTO and can be self-administered; however it usually leads to lower scores. In the literature a power transformation of group mean VAS scores to TTO scores has been proposed. We were able to replicate this finding of a power function. We found coefficients that were very similar to those from the literature, for 183 cancer patients. The relationship existed independently of disease state and health status.